Detection and Metabolic Characterization in DOPA PET/CT of no Treated Brain Metastases of Lung Cancer, Breast Cancer and Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- Assess the sensitivity of 18F DOPA PET-CT for the detection of no treated brain metastases (breast cancer, lung cancer, melanoma), newly diagnosed by MRI and measuring at least 5 mm in diameter.
研究概览
简要总结
About 20 to 30% of patients treated for cancer will have brain metastases. These brain metastases are found more frequently in patients with lung cancer, breast cancer or melanoma. The prognosis of these patients is unfavorable but prolonged survival can be obtained with the local and systemic treatments currently available.
Brain MRI is the gold standard for evaluating brain metastases but has limitations in therapeutic evaluation, partially offset by PET imaging of amino acid metabolism.
Our work aims to compare the performance of PET-DOPA with standard MRI for the detection of brain metastases (≥ 5mm) in lung cancer, breast cancer and melanoma; and to characterize these lesions using dynamic acquisitions obtained with a digital PET camera with high spatial resolution. Having better knowledge of the metabolic characteristics of newly discovered brain metastases, the objective of subsequent studies will be to better assess the per- or post-therapeutic efficacy of radiotherapy and the various systemic therapies available (chemotherapy, targeted therapy, immunotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primitive cancer (brest cancer, lung cancer, melanoma) proven histologically
- •Presence of brain metastasis visualized on MRI, of which at least one measures 5 mm
- •Age > 18 years
- •Patient has valid health insurance
- •Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
排除标准
- •History of irradiation cerebral
- •History of brain surgery for brain metastasis or glial tumor
- •Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the realization of DOPA PET/CT,
- •New anti-tumor treatment started between the discovery of brain metastases and the performance of DOPA PET/CT
- •Other concomitant cancer, or history of cancer in the 5 years preceding the performance of DOPA PET/CT
- •Pregnant or lactating females
- •Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
- •Disorder precluding understanding of trial information or informed consent.
研究组 & 干预措施
F-DOPA PET/CT
Drug: 18 F-DOPA Radiation: F-DOPA PET CT
干预措施: F-DOPA PET/CT (Radiation)
结局指标
主要结局
Assess the sensitivity of 18F DOPA PET-CT for the detection of no treated brain metastases (breast cancer, lung cancer, melanoma), newly diagnosed by MRI and measuring at least 5 mm in diameter.
时间窗: Within 8 months of PET-CT
The sensitivity of PET-DOPA to detect brain metastases greater than 5 mm is determined by the number of metastases detected with PET-DOPA compared to the number of metastases greater than 5 mm detected by MRI
次要结局
- Assess the sensitivity of 18F DOPA PET-CT according to the site of the primary tumor (lung cancer, breast cancer, melanoma) and its characteristics(Within 8 months of PET-CT)